(27 days)
Not Found
No
The document describes a standard incubator that monitors for a fluorescent signal and indicates results based on incubation time or signal detection. There is no mention of AI, ML, or complex data processing beyond simple signal detection and timing.
No
The device is an incubator for biological indicators used in sterilization processes, not for direct medical treatment or diagnosis in patients.
No
This device determines the effectiveness of sterilization processes by incubating and reading biological indicators, which indicates whether sterilization has been successful or not. It does not diagnose a medical condition or disease in a patient.
No
The device description explicitly states "The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs)." This indicates a physical device (incubator) with hardware components for incubation and reading. The software validation mentioned is for the software that controls this physical system, not a standalone software application.
Based on the provided information, the Celerity Incubator is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is used to incubate and read biological indicators (BIs) to determine the effectiveness of sterilization processes. This involves testing a sample (the BI) outside of the human body to provide information about a physiological state (in this case, the sterility of an object).
- Device Description: It specifically mentions monitoring the BI for a fluorescence signal generated as a result of the production of an enzyme (a-glucosidase). This is a biological marker being detected in vitro.
- Performance Studies: The performance studies evaluate the "Fluorescent Read" and its alignment with a "7-day grow out," which is a standard method for assessing the viability of microorganisms in a biological indicator. This further confirms its role in diagnostic testing related to sterilization efficacy.
While the device doesn't directly diagnose a disease in a patient, it performs a diagnostic test on a biological indicator to assess the effectiveness of a process (sterilization) that is critical for patient safety. This falls under the scope of IVD devices, which are used to examine specimens derived from the human body or other sources to provide information for diagnostic purposes. In this case, the "other source" is the biological indicator used to monitor the sterilization process.
N/A
Intended Use / Indications for Use
Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59° C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2.
Test: Software Validation
Acceptance Criteria: The software that controls the system was validated and determined to operate effectively and as designed.
Result: Pass
Test: Qualification Testing with intended Biological Indicators
Acceptance Criteria: Fluorescent Read meets ≥ 97% alignment with 7-day grow out per FDA guidance on Reduced Incubation Time for intended Celerity 5 HP Biological Indicators and Celerity 20 HP Biological Indicators
Result: Pass
Test: Recognition of additional barcodes
Acceptance Criteria: Incubator reads barcodes correctly
Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluorescent Read meets ≥ 97% alignment with 7-day grow out
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 6, 2025
STERIS Corporation Karly Eitzman Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K250061
Trade/Device Name: Celerity Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 8, 2025 Received: January 10, 2025
Dear Karly Eitzman:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Digitally signed by Stephen A. Anisko -S Stephen A. Anisko -S
Stephen A. Anisko -S Stephen A. Anisko -S
Stephen A. Anisko -S Date: 2025.02.06 17:3 Date: 2025.02.06 17:39:07 -05'00'
for: Christopher K. Dugard Division Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Celerity Incubator
Indications for Use (Describe)
Use the Celerity Incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary For Celerity Incubator
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Mrs. Karly Eitzman Contact: Regulatory Affairs Specialist Tel: 440-392-7442 karly eitzman@steris.com
Submission Date: January 8, 2025
K Number: K250061
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | Celerity Incubator |
|---|---|
| Device Class: | Class II |
| Common/usual Name: | Reader/Incubator |
| Classification Name: | Biological Sterilization Process Indicator |
| Classification Number: | 21 CFR 880.2800 |
| Product Code: | FRC |
2. Predicate Device
K223715 – Celerity Incubator
3. Device Description
The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59° C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.
4. Indications for Use
Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.
5. Technological Characteristics Comparison Table
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
Table 1. Technological Characteristics Comparison Table to predicate device
| Feature | Proposed Device
Celerity Incubator | Predicate Device
Celerity Incubator
(K223715) | Comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications
for Use | Use the Celerity Incubator to
incubate and automatically
read STERIS Celerity | Use the Celerity Incubator to
incubate and automatically
read STERIS Celerity | Same |
| Feature | Proposed Device
Celerity Incubator | Predicate Device
Celerity Incubator
(K223715) | Comparison |
| | Biological Indicators for
Steam and Vaporized
Hydrogen Peroxide
sterilization at 55°C - 60°C
for a fluorescent result. | Biological Indicators for
Steam and Vaporized
Hydrogen Peroxide
sterilization at 55°C - 60°C
| |
| Basis of
Readout | Photodiode detects
fluorescence produced by
enzymatic activity that results
from viable biological
indicator organisms. | Photodiode detects
fluorescence produced by
enzymatic activity that results
from viable biological
indicator organisms. | Same |
| Incubation
Temperature
Range | 55 - 60 °C | 55 - 60 °C | Same |
| Voltage
Range | 100-240 VAC with 12 VDC
conversion | 100-240 VAC with 12 VDC
conversion | Same |
| Test Capacity | 8 wells | 8 wells | Same |
| Calibration | Factory calibration - no
calibration by customer | Factory calibration - no
calibration by customer | Same |
| Incubation
Time | 5 minutes or 20 minutes,
depending on Biological
Indicator | 5 minutes or 20 minutes,
depending on the Biological
Indicator | Same |
| Fluorescence
Detection | UV LEDs are used to excite
the fluorescent molecule
produced by enzyme cleavage
of the fluorogenic substrate
contained in the BI's media.
The emitted light is detected
by a photodiode. | UV LEDs are used to excite
the fluorescent molecule
produced by enzyme cleavage
of the fluorogenic substrate
contained in the BI's media.
The emitted light is detected
by a photodiode. | Same |
| Indication of
Results | Positive - audible alarm,
visual LED lights and screen
Negative – optional alarm,
visual indication with LED
lights and LCD screen
User must acknowledge
results | Positive – audible alarm,
visual LED lights and screen
Negative - optional alarm,
visual indication with LED
lights and LCD screen
User must acknowledge
results | Same |
| System
Operation | The reader/incubator wells
are arranged in 2 banks of 4
wells and preset to 59°C. The
user scans the barcode on the
label of an activated BI using | The reader/incubator wells
are arranged in 2 banks of 4
wells and preset to 59°C. The
user scans the barcode on the
label of an activated BI using | Same |
| Feature | Proposed Device
Celerity Incubator | Predicate Device
Celerity Incubator
(K223715) | Comparison |
| | the system's barcode scanner
and places it into an open
well. The system detects the
well the BI was placed into
and begins measurement of
fluorescence; a blinking
yellow light indicates the
incubation is in process and
the read initiated. The | the system's barcode scanner
and places it into an open
well. The system detects the
well the BI was placed into
and begins measurement of
fluorescence; a blinking
yellow light indicates the
incubation is in process and
the read initiated. The | |
| | System uses information from
the barcode to apply the
appropriate algorithm to the
well. A "positive" reading is
interpreted as an indication of
a potential sterilization cycle
failure. A "positive" finding
is indicated to the user by red
light on the front panel
adjacent to the well, by an
audible alarm, and by text
displayed on the LCD screen.
The alarm must be muted by
the operator when a positive
result is obtained. The LCD
screen provides instructions
for the user to turn off the
alarm for that specific BI.
Should another BI become
"positive", the alarm will
sound again and the above
actions are repeated. | System uses information from
the barcode to apply the
appropriate algorithm to the
well. A "positive" reading is
interpreted as an indication of
a potential sterilization cycle
failure. A "positive" finding
is indicated to the user by red
light on the front panel
adjacent to the well, by an
audible alarm, and by text
displayed on the LCD screen.
The alarm must be muted by
the operator when a positive
result is obtained. The LCD
screen provides instructions
for the user to turn off the
alarm for that specific BI.
Should another BI become
"positive", the alarm will
sound again and the above
actions are repeated. | |
| | If the result is not positive at
the end of the incubation
time, the result is negative.
Negative results are identified
by a green light on the front
panel adjacent to the well
with the "negative" BI and by
text on the LCD. In addition,
an optional alarm is available
for negative results. | If the result is not positive at
the end of the incubation
time, the result is negative.
Negative results are identified
by a green light on the front
panel adjacent to the well
with the "negative" BI and by
text on the LCD. In addition,
an optional alarm is available
for negative results. | |
6
7
Summary of Non-Clinical Performance Testing 6.
8
Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Software Validation | The software that controls the system was validated | |
| and determined to operate effectively and as designed. | Pass | |
| Qualification Testing | ||
| with intended | ||
| Biological Indicators | Fluorescent Read meets ≥ 97% alignment with 7-day | |
| grow out per FDA guidance on Reduced Incubation | ||
| Time for intended Celerity 5 HP Biological Indicators | ||
| and Celerity 20 HP Biological Indicators | Pass | |
| Recognition of | ||
| additional barcodes | Incubator reads barcodes correctly | Pass |
Table 2. Performance Testing
7. Conclusion
The Celerity Incubator has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K223715), Class II (21 CFR 880.2800), product code FRC.